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HRV in Patients Treated With Spinal Cord Stimulation

Sponsor
Moens Maarten (Other)
Overall Status
Completed
CT.gov ID
NCT03768791
Collaborator
(none)
23
Enrollment
1
Location
2
Arms
20
Actual Duration (Days)
35
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.

Condition or Disease Intervention/Treatment Phase
  • Other: SCS is switched off
  • Other: SCS is switched on
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
Actual Study Start Date :
Dec 1, 2018
Actual Primary Completion Date :
Dec 21, 2018
Actual Study Completion Date :
Dec 21, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: SCS off

Other: SCS is switched off
Spinal cord stimulator is switched off for 12 hours
Experimental: SCS on

Other: SCS is switched on
Spinal cord stimulator is on

Outcome Measures

Primary Outcome Measures

  1. Heart rate variability changes [Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]

    The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off)

Secondary Outcome Measures

  1. Pain intensity scores [Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]

    Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Subject is at least 18 years old.

  • Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.

  • Cognitive and language functioning enabling coherent communication between the examiner and the participant.

Exclusion Criteria:

  • The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).

  • The use of medication that directly modifies autonomic control (for example beta-blockers).

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Brussel Jette Brussel Belgium 1090

Sponsors and Collaborators

  • Moens Maarten

Investigators

  • Principal Investigator: Maarten Moens, Prof. dr., Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Moens Maarten, principal investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT03768791
Other Study ID Numbers:
  • SYNCHRO
First Posted:
Dec 7, 2018
Last Update Posted:
Jun 18, 2019
Last Verified:
Jun 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Moens Maarten, principal investigator, Universitair Ziekenhuis Brussel
Spinal Cord Stimulation
Heart rate variability
Additional relevant MeSH terms:
Syndrome
Failed Back Surgery Syndrome

Study Results

No Results Posted as of Jun 18, 2019